Medical measuring device and method

ABSTRACT

A subsurface wound measuring device and method are provided for measuring a subsurface wound or cavity of a patient, the device including a flexible strip having a first and second section, said sections having a first and second ends respectively with an intermediate bend being located between the first and second ends. The first end is adapted for being located internally to a patient, the second end being adapted for being located externally to the patient. The first and second sections have generally concave shaped cross-sections with measuring indicia being located along at least one of the sections. The device also optionally includes a measuring strip and a receiver mounted on the second end for receiving the measuring strip, where the measuring strip and the flexible strip form complementary structure for measuring a subsurface wound or cavity.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of and claims the benefit of U.S.patent application Ser. No. 11/129,614, filed May 13, 2005, entitled“Medical Measuring Device and Method,” now U.S. Pat. No. 7,662,112,issued Feb. 16, 2010.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical measuring devices andmethods, and in particular to wound modeling and treatment applicationsof same.

2. Description of the Related Art

In the medical field, wound treatment encompasses a wide variety ofprocedures, pharmacologicals, devices and equipment. Health careinstitutions and other providers commonly devote substantial resourcesto wound treatment. Treating open wounds, such as those associated withdecubitus pressure ulcers and other chronic conditions, can beparticularly challenging. For example, wound care facilities commonlyspecialize in the treatment of open, slow-healing wounds.

Certain types of open wounds exhibit subdermal voids and pockets wherebyintact skin areas are undermined by infected and necrotic tissue. Suchsubdermal conditions can be difficult to treat because they are notreadily observable and do not respond to surface-applied treatmentprotocols. For example, an undermined wound may appear to be closing atthe epidermis, when in fact subdermal conditions are actually worsening.Determining the extent of subsurface wounds is an important aspect ofmonitoring treatment progress and selecting appropriate treatmentprotocols.

The related art includes devices and procedures for measuring andmodeling open and subsurface wounds. For example, US Marketing ServicesWorldwide (USMS) of Miami, Fla. offers a Wound Stick™ Measuring Systemwith calibrated rulers adapted for measuring open wounds and a WoundStick Tunneler™ for insertion into undermined pressure wounds. Themeasurements can be used to produce a WoundMap™ record, which documentsthe extent of subsurface injury. Another related art device is shown inJapanese Patent Abstract Publication No. 2004-073,769, which discloses adecubitus pocket measure including a probe and a measure, which enablemarking the skin surface above the undermined portion of the wound. Theuse of this device is described in Kosaka, M. et al., “Pocket Measure”:an Exclusive Tool for Measuring and Recording Pressure Ulcer Pockets,Journal of Plastic and Reconstructive Surgery, August 2004, pp. 644-25.

A wound measuring device for open and subsurface wounds would ideally beadapted for obtaining multiple measurements of irregular shapes, such asundermined wounds, and using such measurements for generatingtwo-dimensional or three-dimensional models. Patient comfort and use ofoperation are additional considerations. The present invention addressesthese considerations. Heretofore there has not been available a medicalmeasuring device and method with the advantages and features of thepresent invention.

SUMMARY OF THE INVENTION

In the practice of one aspect of the present invention, a woundmeasurement device is provided, which includes a flexible strip adaptedfor bending at an elbow whereby first and second sections withrespective first and second ends are formed. The strip includes an uppersurface with a measuring structure and a configuration adapted forinserting, guiding and manipulating same within a wound. Alternativeembodiment measuring devices include different end constructions, guideand measuring strips adapted for cooperative, sliding engagement, andother optional features. In the practice of one aspect of the method ofthe present invention, multiple dimensions corresponding to the size andshape of the wound are determined whereby it can be modeled in two orthree dimensions. The method can include monitoring the patient'sprogressive healing and response to treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a subsurface wound measuring deviceembodying the present invention.

FIG. 2 is a cross-section of a wound, with the measuring device partlyinserted therein.

FIG. 3A is a cross-section of another wound, with the measuring devicepartly inserted therein.

FIG. 3B is another cross-section of the wound shown in FIG. 3A, showingadditional measurements being taken with the measuring device partlyinserted in another orientation.

FIG. 4 is a perspective view of a subsurface wound measuring devicecomprising an alternative embodiment of the present invention.

FIG. 5 is a fragmentary, perspective view of a subsurface woundmeasuring device comprising another alternative embodiment of thepresent invention.

FIGS. 6A and 6B are perspective views of a subsurface wound measuringdevice comprising an alternative embodiment of the present invention.

FIG. 7 is a perspective view of a measuring strip thereof.

FIGS. 8 and 9 are perspective views of a subsurface wound measuringdevice comprising another alternative embodiment of the presentinvention.

FIG. 10 is a perspective view of a subsurface wound measuring devicecomprising another alternative embodiment of the present invention.

FIG. 11 is a fragmentary, perspective view thereof, taken generallywithin circle 11 in FIG. 10.

FIG. 12 is a fragmentary, longitudinal cross-sectional view thereof,taken generally along line 12-12 in FIG. 11.

FIG. 13 is a fragmentary, perspective view of a subsurface woundmeasuring device comprising another alternative embodiment of thepresent invention.

FIG. 13A is a fragmentary, perspective view of a subsurface woundmeasuring device, which can be fitted with various end configurations,as shown in cross-sectional FIGS. 14-16 taken generally along line14/15/16 in FIG. 13A.

FIG. 14 is a fragmentary, cross-sectional view taken generally alongsection line 14 in FIG. 13A and showing a modified aspect or embodimentof the subsurface wound measuring device of the present invention.

FIG. 15 is a fragmentary, cross-sectional view taken generally alongsection line 15 in FIG. 13A and showing another modified aspect orembodiment of the subsurface wound measuring device of the presentinvention.

FIG. 16 is a fragmentary, cross-sectional view taken generally alongsection line 16 in FIG. 13A and showing another modified aspect orembodiment of the subsurface wound measuring device of the presentinvention.

FIG. 17 is a fragmentary, top plan view of another alternative woundmeasuring device, which is adapted for retrieving tissue and fluidsamples.

FIG. 18 is a fragmentary, side elevational view thereof, shown in atissue or fluid sample gathering position within a wound, takengenerally along line 18 in FIG. 17.

FIG. 19 is a fragmentary, cross-sectional view thereof, taken generallyalong line 19 in FIG. 17.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS I. Introduction andEnvironment

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which may be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure.

Certain terminology will be used in the following description forconvenience in reference only and will not be limiting. For example, up,down, front, back, right and left refer to the invention as oriented inthe view being referred to. The words “inwardly” and “outwardly” referto directions toward and away from, respectively, the geometric centerof the embodiment being described and designated parts thereof.Forwardly and rearwardly are generally in reference to the direction oftravel, if appropriate. Said terminology will include the wordsspecifically mentioned, derivatives thereof and words of similarmeaning.

II. Wound Measuring Device 2

Referring to the drawings in more detail, the reference numeral 2generally designates a subsurface wound measuring device embodying thepresent invention. Without limitation on the generality of usefulapplications of the device 2, as shown in FIG. 2, it is particularlyuseful for obtaining linear dimensions corresponding to the size andconfiguration of an undermined subsurface wound cavity 4, which includesan opening 5 at the skin layer 6, a sidewall 7 with an inner portion 7 aadjacent to a wound base 8 an outer portion 7 b adjacent to the opening5. The sidewall inner portion 7 a is larger than the outer portion 7 b,whereby the wound cavity 4 undermines the patient's skin layer 6. Suchan undermined configuration presents difficulties in directly obtainingmeasurements since the sidewall inner portion 7 a is largely obscured.The wound cavity 4 can extend to the fascia layer and beyond. Themeasuring device 2 is adapted for taking multiple linear measurements ofa wound, not only of the skin opening but also of the irregularconfiguration of the undermined portion, including lengths, widths anddepths. Such measurements can be used to generate a model of the woundin two or three dimensions.

The measuring device 2 generally includes a flexible, upwardly-concavestrip 10 with first and second ends 12, 14. The first end 12 can beradiused as shown for patient comfort. The concavity of the strip 10facilitates bending at an elbow 13 whereby first and second sections 20a, 20 b are formed adjacent to the ends 12, 14 respectively. Therespective lengths of the sections 20 a, 20 b can vary along the lengthof the strip 10, depending upon where the elbow 13 is formed. A tubularsleeve 16 is mounted on the strip 10 adjacent to its second end 14, andincludes a sleeve passage 17. The sleeve 16 is adapted for grasping,e.g. with the thumb and forefinger, whereby the device 2 can bepositioned, guided and manipulated within the wound cavity 4.

The strip 10 includes an upper surface 18, which can be provided withmeasuring structure comprising a printed scale 19 corresponding tosuitable linear values represented by indicia 21, such as centimeters.The scale 19 can extend for the length of the strip 10 and can originateat the first end 12.

FIG. 2 shows the device 2 placed in the wound cavity 4 for measuringsame according to the method of the present invention. An elbow 13 canbe formed with the strip first section 20 a extending generallyhorizontally therefrom to a first point PI at its first end 12 on thecavity sidewall inner portion 7 a. A first distance L1 from the elbow 13to PI can be measured, observed and recorded. The depth D, as measuredfrom point P3 to P4 can be determined with the measuring device 2 (FIG.2). It will be appreciated a number of measurements can be taken, asappropriate for the nature of the wound, the precision requirements formeasuring same, etc. FIGS. 3A and 3B show the measuring device 2 beingused to obtain measurements of the wound 4 in a different area thereof.For example, the undermined, wound inner portion 7 a can extend inmultiple directions from the wound opening 5. Thus, a first lengthmeasurement is taken to determine L1 in a first undermined area, asecond length measurement determines L2 in a second undermined area andthe third length measurement L3 is taken across the opening 5. Theoverall length of the wound 4 is thus the sum of L1+L2+L3. The depth Dof the wound 4 can also be determined as shown. Additional measurementscan be taken as needed, for example to determine distances betweenvarious opposite points on the wound sidewall. Given the generallyirregular configurations of wounds, which configurations change withhealing, it will be appreciated that multiple dimensional values may berequired in order to accurately model a wound in two or three dimensionsand monitor its healing progress.

III. Alternative Embodiment Wound Measuring Devices

FIG. 4 shows a measuring device 52 comprising an alternative embodimentof the present invention. The device 52 includes a removable tip 54adapted for mounting on a strip 56 second end 58 to facilitate gripping,guiding, inserting and manipulating same. FIG. 5 shows anotheralternative embodiment measuring device 60 of the invention with acollar 62 including an arcuate slot 64 slidably receiving the strip 10or the strip 56 and adapted for gripping to facilitate inserting,positioning and guiding the strip 10 or 56.

FIGS. 6A, 6B and 7 show another alternative embodiment wound measuringdevice 102, including a measuring strip 110 with first and second ends112, 114 associated with respective first and second sections 120 a, 120b separated by an elbow 113. The measuring strip 110 has an arcuate,upwardly-concave configuration with an upper surface 118 including ameasuring structure comprising a scale 119. The measuring strip 110 isadapted for use in conjunction with the measuring device 2 describedabove, which in this configuration provides a guide strip 10 for guidingand directing the measuring strip 110 into and within the wound cavity4. As shown in FIGS. 6A and 6B, the sleeve passage 17 telescopically andslidably receives the measuring strip 110, which forms an elbow 113adjacent to the elbow 13 whereby the measuring strip sections 120 a, 120b partly overlie the respective guide strip sections 20 a, 20 b. Themeasuring strip 110 can thus be advanced into the wound cavity 4 andextended to engage its sidewalls 7 a, 7 b, with the guide strip 10providing a layer of protection and between the measuring strip 110 andthe patient, particularly along the wound base 8. FIG. 7 shows themeasuring strip 110 separated from the guide strip 10. It will beappreciated that the guide and measuring strips 10 and 110 (FIGS. 1 and7 respectively) can be used together in the measuring device 102configuration described above or independently.

FIGS. 8 and 9 show the measuring strip 110 fitted with a movable sleeve130 having a passage 132, which telescopically and slidably receives themeasuring strip 110. The movable sleeve 130 is adapted for providing anindex whereby a location along the length scale 119 can be marked forreference, e.g. when the measuring strip 110 is extracted. The strip 10can also be fitted with the movable sleeve 130 for indexing particularlocations along its length.

The measuring strip 110 can be placed on the guide strip 10 of themeasuring device 2, and held digitally in place to mark a spot (e.g. theelbow 13 position) for a measurement, which can be readily read when theguide and measuring strips 10, 110 are extracted together from the woundcavity 4. Alternatively, any relatively stiff, sterile availablematerial, such as a cotton-tipped applicator, can be used with the guidestrip 10 to obtain a measurement. The sleeve 130 shown in FIGS. 8 and 9can be freely movable and also require external fixation to hold andmark a position, or it can have an internal fixing and releasing deviceor spring.

FIGS. 10-12 show an alternative embodiment measuring strip 222, whichincludes a flat or blunt first end structure 224, which is adapted forabutting a wound cavity surface. The blunt-ended configuration of theend structure 224, which presents a relatively flat engagement face 226,reduces or eliminates penetration into tissue within wound cavities,whereby relatively accurate length measurements can be taken withminimal patient discomfort. The end structure 224 includes a fillet 228,which flares into the upper surface of the measuring strip 222.

FIG. 13 shows another alternative embodiment measuring strip 232, whichincludes an arcuate, upwardly-concave lip 234 forming a first endstructure 236 with a generally tubular configuration adapted forminimizing patient discomfort and providing accurate readings. FIGS.14-16 comprise fragmentary, cross-sectional views taken generally alongline 14/15/16 in FIG. 13A, which shows a portion of alternativeembodiment measuring strips 242, 252 and 262 and the general location ofend structures 246, 256 and 266 in relation thereto. FIGS. 14-16 showthe further alternative embodiment measuring strips 242, 252 and 262respectively with the end structures 246, 256 and 266 including flanges244,254 and 264. The end structure 246 is integrally formed with themeasuring strip 242. The end structures 256, 266 comprise separate clipsattached to the measuring strips 252, 262 with the flanges 254, 264depending downwardly and extending upwardly therefrom respectively.

FIGS. 17-19 show another alternative embodiment biopsy/measuring device302 comprising a measuring strip 310 with a first end 312 forming adistally-opened receptacle 330 adapted for receiving and extracting atissue or fluid sample 332, e.g. for culture purposes in connection witha biopsy. The device 302 can be used for sample collecting, measuring orboth in one or more procedures. For example, in connection withmeasuring an undermined wound cavity, samples can be collected foranalysis whereby treatment progress and potential pathogenic conditionscan be monitored by analyzing the collected samples.

It will be appreciated that various other end structures can be providedfor the guide and measuring strips, including disposable tips andabsorbable materials for applying pharmaceuticals or taking fluidsamples. Moreover, the guide and measuring strip end structures can bemodified by medical practitioners as necessary to accommodate a widerange of wound cavities among patients having unique conditions andtreatment procedures.

It is to be understood that the invention can be embodied in variousforms, and is not to be limited to the examples discussed above. Othercomponents and configurations can be utilized in the practice of thepresent invention.

Having thus described the invention, what is claimed as new and desiredto be secured by Letters Patent is:
 1. A subsurface wound measuringdevice for measuring at least one physical parameter of a patient with asubsurface wound having a cavity with a cavity opening and a side wall,which comprises: a flexible guide strip with a first end, a second end,an intermediate bend, a receiver, a first section, and a second section;said first end adapted for being located internally to a patient; saidsecond end adapted for being located externally to said patient; saidreceiver being tubular and including a passage, said receiver beingadapted for rotating the strip; said receiver being mounted on saidsecond end; said first section having an arcuate, transverse,concave-shaped cross-section, said second section having an arcuate,transverse, concave-shaped cross-section, the first and second sectionsseparating the second end from the first end, said strip beingconfigured for positioning by said second end and forming theintermediate bend between the first section terminating at said firstend and the second section terminating at said second end; said flexibleguide strip having a lip, an exterior surface and a measuring structure,the lip being connected to said first end; said flexible guide stripfurther having a receptacle with a closed end at said first end and anopening located in spaced relation and oriented away from said firstend; said receptacle opening providing access to said receptacle; saidmeasuring structure comprising measuring indicia located on the exteriorsurface adjacent to said first end of said strip, and adapted formeasuring a subsurface dimension of said wound; a measuring strip havingfirst and second sections, having first and second ends respectively,said first section having an arcuate, transverse, concave-shapedcross-section, said second section having an arcuate, transverse,concave-shaped cross-section; said measuring strip sliding in overlyingrelation with respect to said guide strip and forming an intermediatebend between the measuring strip first and second sections, which atleast partly overlie said guide strip first and second sectionsrespectively; said measuring strip being adapted for beingtelescopically and slidably received in said tubular receiver passage;said measuring strip including an exterior surface and a plurality ofmeasuring indicia; said measuring strip having an arcuate, transverse,concave-shaped cross-sectional configuration, said plurality ofmeasuring indicia being located on said measuring strip exterior surfaceand being adapted for measuring the wound; said measuring stripmeasuring indicia and said guide strip measuring indicia comprising acomplementary measuring scale adapted for measuring the wound; and acollar or sleeve with a passage extending therethrough and slidablyreceiving said flexible strip in a frictional, gripping relationtherewith whereby said collar or sleeve is adapted to be moved intoposition to maintain the bend and lock the position of the flexiblestrip into place.
 2. The device according to claim 1, which includes:said guide structure comprising a receiver mounted on said guide stripsecond end; said receiver including a passage; and said receiver passagetelescopically receiving said measuring strip.
 3. The device accordingto claim 2 wherein said receiver is tubular and extends parallel withrespect to said guide strip.
 4. The device according to claim 1 whereinsaid receptacle closed end has a radiused configuration.
 5. A subsurfacewound measuring device for measuring at least one physical parameter ofa patient with a subsurface wound having a cavity with a cavity openingand a sidewall, which comprises: a flexible guide strip with a firstend, a second end, an intermediate bend, a receiver, a first section anda second section; said first end adapted for being located internally toa patient; said second end adapted for being located externally to saidpatient; said receiver being tubular and including a passage, saidreceiver being adapted for rotating the strip; said receiver beingmounted on said second end; said first section having an arcuate,transverse, concave-shaped cross-section, said second section having anarcuate, transverse, concave-shaped cross-section, the first and thesecond sections separating the second end from the first end, said stripbeing configured for positioning by said second end and forming theintermediate bend between the first section terminating at said firstend and the second section terminating at said second end; said flexibleguide strip having a lip, an exterior surface and a measuring structure,the lip being connected to said first end; said flexible guide stripfurther having a receptacle with a closed end at said first end and anopening located in spaced relation and oriented away from said firstend; said receptacle opening providing access to said receptacle; saidmeasuring structure comprising measuring indicia located on the exteriorsurface adjacent to said first end of said strip, said measuring indiciabeing adapted for measuring the wound; a measuring strip having firstand second sections, having first and second ends respectively, saidfirst section having an arcuate, transverse, concave-shapedcross-section, said second section having an arcuate, transverse,concave-shaped cross-section; said measuring strip sliding in overlyingrelation with respect to said guide strip and forming an intermediatebend between the measuring strip first and second sections, which atleast partly overlie said guide strip first and second sectionsrespectively; said measuring strip being adapted for beingtelescopically and slidably received in said tubular receiver passage;said measuring strip including an exterior surface and a plurality ofmeasuring indicia; said measuring strip having an arcuate, concave,transverse cross-sectional configuration, said plurality of measuringindicia being located on said measuring strip exterior surface and beingadapted for measuring the wound; and said measuring strip measuringindicia and said guide strip measuring indicia comprising acomplementary measuring scale adapted for measuring the wound.
 6. Thedevice according to claim 5, wherein said receptacle has a radiusedconfiguration.